FDA.reportPublic FDA data

KOMET Dental Tungsten Carbide Burs

Primary DI
E226000453A11
Brand
KOMET Dental Tungsten Carbide Burs
Company
Gebr. Brasseler GmbH & Co. KG
Model
H33.314.009.A1
Catalog number
H33.314.009
Published
2023-01-31
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
EJLBUR, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJLBur, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E226000453A11PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Carbide dental bur, reusableA rotary cutting device made of high-grade steel, the working end of which is made from, or coated with, tungsten carbide, and which is designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, e.g., teeth or bone. It can also be used to cut hard metals, plastics, porcelains and similar materials. It is available in various shapes (e.g., cylinder, disk, sphere, oval). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
317409001
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
14053613001998KOMET Surgical BurNC0612.004..M0NC0612.004.2023-01-31
14053613002322KOMET Surgical BurNS0101.012..M0NS0101.012.2023-01-31
14053613053232KOMET Surgical BurNS4101.009..M0NS4101.009.2023-02-01
14053613054222KOMET Surgical BurNS4001.027..M0NS4001.027.2023-02-01
14053613167298KOMET Surgical BurNS4002.027..M0NS4002.027.2023-02-01
14053613174227KOMET Surgical Saw BladeKMS2595.M62..M2KMS2595.M62.2023-02-01
14053613201060KOMET Surgical Saw BladeKM71125.C00..M0KM71125.C00.2023-09-29
14053613205525KOMET Surgical BurNC0186.016..M0NC0186.016.2023-02-01
14053613266892KOMET Surgical BurND1905.009..M0ND1905.009.2023-02-01
14053613266915KOMET Surgical BurND1903.004..M0ND1903.004.2023-01-31
14053613267578KOMET Surgical BurNS0101.012..K2NS0101.012.2023-01-31
14053613268599KOMET Surgical BurNS4101.009..K2NS4101.009.2023-02-01
14053613268612KOMET Surgical BurNS3601.027..K2NS3601.027.2023-02-01
14053613268650KOMET Surgical BurNS4002.027..K2NS4002.027.2023-02-01
14053613272435KOMET Surgical BurND1903.004..K2ND1903.004.2023-01-31
14053613273418KOMET Surgical BurND2001.004..K2ND2001.004.2023-01-31
14053613274491KOMET Surgical Saw BladeKM8672. AC..K2KM8672. AC.2023-02-01
14053613274514KOMET Surgical Saw BladeKM8673. AC..K2KM8673. AC.2023-02-01
14053613275160KOMET Surgical Saw BladeKM005.000..K2KM005.000.2023-02-01
14053613275658KOMET Surgical Saw BladePC5160.000..K2PC5160.000.2023-02-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
E0HM72C1170FG1n/aHager & Meisinger Gesellschaft mit beschränkter HaftungEJL2026-10-23
E0HM72C169FG1n/aHager & Meisinger Gesellschaft mit beschränkter HaftungEJL2026-10-23
08404535020779Brasseler USAPeter Brasseler Holdings, LLCEJL2026-10-20
08404535020809Brasseler USAPeter Brasseler Holdings, LLCEJL2026-10-20
08404535036985Brasseler USAPeter Brasseler Holdings, LLCEJL2026-10-01
00810194409387AiraAIRA, LLCEJL2026-08-25
00810194409431AiraAIRA, LLCEJL2026-08-25
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00810194409462AiraAIRA, LLCEJL2026-08-25
00810194409486AiraAIRA, LLCEJL2026-08-25
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00810194409592AiraAIRA, LLCEJL2026-08-25
00810194409608AiraAIRA, LLCEJL2026-08-25
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00810194409837AiraAIRA, LLCEJL2026-08-25
00810194409912AiraAIRA, LLCEJL2026-08-25
00810194409943AiraAIRA, LLCEJL2026-08-25
00810194409950AiraAIRA, LLCEJL2026-08-25
00810194409981AiraAIRA, LLCEJL2026-08-25
00810226100022AiraAIRA, LLCEJL2026-08-25
00810226100060AiraAIRA, LLCEJL2026-08-25
00810226100138AiraAIRA, LLCEJL2026-08-25
00810226100213AiraAIRA, LLCEJL2026-08-25
00810226100268AiraAIRA, LLCEJL2026-08-25
00810226100275AiraAIRA, LLCEJL2026-08-25